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I concur that petitioners' comment should have been addressed by respondent in the
re-certification proceedings. The submission of comments by the public is required
by respondents' own procedures, which it violated by refusing to answer or even
acknowledge the oppositions submitted.
Nevertheless, a certification and re-certification proceeding for the determination of
non-abortifacience does not require a public hearing. The Food and Drug
Administration, as a regulatory agency, does not exercise its quasi-judicial functions
when it determines whether a contraceptive is safe, effective, and a nonabortifacient. In certification and re-certification proceedings, the Food and Drug
Administration merely looks at the requirements of the law and applies it. Its
scientific testing and gathering of medical and pharmacological data do not require
an.adjudication of rights of the parties before it. Public participation, however, is still
necessary for purposes of transparency since any public act is subject to public
scrutiny and criticism.
I
The Food and Drug Administration was created by Republic Act No. 3720[1] to
regulate food, drug, and cosmetic manufacturers and establishments.[2] In 1982,
the Food and Drug Administration was abolished and its functions were assumed by
the Bureau of Food and Drugs.[3] In 2009, the Bureau of Food and Drugs was
renamed the Food and Drug Administration.[4] Republic Act No. 9711 outlined the
Food and Drug Administration's regulatory capabilities, including the development
and issuance of "standards and appropriate authorizations that would cover
establishments, facilities and health products."[5]
Among the authorizations issued by the Food and Drug Administration is the
Certificate of Product Registration[6] of all health products or "food, drugs,
cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and
household/urban hazardous substances and/or a combination of and/or a derivative
thereof,"[7] consistent with its mandate to "insure safe and good quality [supplies] of
food, drug[s] and cosmetic[s]."[8]
Considering the highly technical nature of the registration and certification process,
the Food and Drug Administration is further subdivided into four (4) research
centers: first, the Center for Drug Regulation and Research; second, the Center for
Food Regulation and Research; third, the Center for Cosmetic Regulation and
Research; and fourth, the Center for Device Regulation, Radiation Health and
Research.[9]
Prior to the issuance of a Certificate of Product Registration of an established
drug,[10] the Center for Drug Regulation and Research must first review the
technical specifications of the drug, in particular:
1. Application Letter
4/21/2020, 9:19 AM
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